Cleared Traditional

K840745 - STERILE ABSORBENT GAUZE BURN & SOUND

K840745 · Chesebrough-Pond'S U.S.A. Co. · General & Plastic Surgery device

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Apr 1984

Decision

61d

Days

Risk

K840745 is an FDA 510(k) clearance for the STERILE ABSORBENT GAUZE BURN & SOUND. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Chesebrough-Pond'S U.S.A. Co. (Walker, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Chesebrough-Pond'S U.S.A. Co. devices

FDA 510(k) Submission Details - K840745

510(k) Number	K840745 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 22, 1984
Decision Date	April 23, 1984
Days to Decision	61 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

54d faster than avg

Panel avg: 115d · This submission: 61d

Pathway characteristics

Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

All 273

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K840745.

COMFEEL ULCUS SHEET

K840438 · Coloplast A/S · Nov 1984

DUODERM FLEXIBLE HYDROACTIVE DRESSINGS

K841287 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984

HYDRON WOUND DRESSING FAST SEAT KIT

K832699 · National Patent Development Corp. · Apr 1984

NON ADHERENT BANDAGE/SHEET

K833730 · American Medical Disposable, Inc. · Jan 1984

DECUBITUS CARE ABSORBENT DRESSING

K832407 · American Pharmaseal Div. Ahsc · Jan 1984

BARD ABSORPTION DRESSING

K831710 · C.R. Bard, Inc. · Jan 1984

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K840745

Chesebrough-Pond'S U.S.A. Co.

Walker, MI · US

Regulatory profile

33 submissions 30 cleared

91% clearance rate · Active in General & Plastic Surgery

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: April 23, 1984. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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510k Database

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